Impulse Dynamics Secures Transitional Pass-through (TPT) Incremental Payment for the Optimizer Smart System

“Heart failure patients in the U.S. received much needed assistance today in their quest for access to breakthrough treatment. Clinical improvements demonstrated by CCM therapy are now within reach,” said Chris Baer, vice president of commercial operations, Impulse Dynamics. “We applaud CMS for recognizing the critical importance of improving patient access to Optimizer Smart technology. Because of this, hope is finally here for a very large population of heart failure patients who had until now gone without further treatment options.”

The Optimizer Smart System offers CCM therapy for heart failure patients with reduced ejection fraction who are still suffering from the debilitating effects of the disease despite guideline-directed medical therapy. CCM is a unique electrical therapy delivered during the heart’s absolute refractory period, which is just after the heart muscle contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm. It helps the heart contract more forcibly, increasing the efficiency of each beat.

“Finally, we have an answer for a huge population of Class III heart failure patients who experience poor quality of life despite optimal medical management,” said Dr. Gery Tomassoni an electrophysiologist and Director of Cardiology Research at Central Baptist Hospital in Lexington, KY. “I am encouraged that CMS understands the important place CCM therapy represents in the treatment continuum for heart failure. Inadequate payment presents a major barrier for providers seeking to treat patients with breakthrough technologies. This ruling helps remove that barrier and will allow us to make CCM accessible for patients that currently have few alternatives.”

The Optimizer Smart System is the only CCM device approved by the U.S. Food and Drug Administration to improve six-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for CRT, and have a left ventricular ejection fraction (LVEF) ranging from 25 to 45 percent. CCM aims to help the 70 percent of patients with chronic heart failure that are not eligible for CRT to manage their disease.

Designed to address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough Device designation from the FDA in 2015. It is the only Breakthrough Device to go before an FDA Advisory Committee (the Circulatory System Devices Panel) on Dec. 4, 2018, receiving a unanimous recommendation for approval based on their assessment of benefit versus risk. Optimizer then went on to receive FDA approval on March 21, 2019.

About the Optimizer Smart and CCM Therapy

CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical therapy delivered by the implantable Optimizer Smart device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The Optimizer Smart has been implanted in more than 4,000 patients and is currently available in the U.S., Europe, China, Brazil, India and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies of the Optimizer Smart, including several randomized controlled trials. The results have been published in more than 80 papers in leading medical journals.

About Impulse Dynamics

Impulse Dynamics is a medical device company dedicated to transforming the treatment of chronic heart failure. The company has operations in the United States, Europe and Asia. For more information please visit www.impulse-dynamics.com.